(LPX.L) Lipoxen PLC Buy/Sell

RNS Number : 8087H Lipoxen PLC 01 March 2010

For immediate release 1 March 2010

Lipoxen plc

('Lipoxen' or 'the Company')

ErepoXen Phase II Trial Commences

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce that its partner, the Serum Institute of India ("Serum Institute"), has now commenced first dosing of patients for Lipoxen's expanded Phase II trial of ErepoXen® in India.

Lipoxen's ErepoXen product candidate is an enhanced polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia caused by chronic renal (kidney) failure or chemotherapy. ErepoXen uses Lipoxen's PolyXen® platform technology to attach polysialic acid (PSA), a polymer of sialic acid (a biodegradable sugar that is found naturally in the human body) to protein drugs.

The trial is an open label Phase II ICH-GCP compliant trial involving 30 patients with anaemia, across 6 trial centres in India. The primary endpoints of the trial are improved red blood cell count, reticulocytes, hemoglobin and hematocrit. Secondary endpoints will measure safety, a reduction in the frequency of injections versus current EPOs, and immunogenicity. Clinigene International Ltd, a Biocon group company based in Bangalore is the contract research organization running the trial. Results on this trial are scheduled to be reported early Q3 this year.

As reported in early February, the Serum Institute agreed to accelerate the product candidate towards marketability by expanding the planned trial into a fully integrated Phase II US FDA compliant trial and to meet the additional costs associated.

Commenting on the Phase II trial, M. Scott Maguire, CEO of Lipoxen, said: "The commencement of our Phase II ErepoXen trial with the Serum Institute under European regulations in India is a very exciting step forward. EPO is a currently $9B drug and is injected 1-3 times per week. Our EPO is designed to last for one month so we are very excited about moving this potential blockbuster candidate into patient trials having had a successful Phase I trial. Not only will the trial measure the potential benefits of our enhanced EPO product candidate, but positive results will assist Lipoxen to execute further licensing deals that combine our versatile PolyXen® platform technology with existing protein drugs."

RNS Number : 8087H Lipoxen PLC 01 March 2010

For immediate release 1 March 2010

Lipoxen plc

('Lipoxen' or 'the Company')

ErepoXen Phase II Trial Commences

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce that its partner, the Serum Institute of India ("Serum Institute"), has now commenced first dosing of patients for Lipoxen's expanded Phase II trial of ErepoXen® in India.

Lipoxen's ErepoXen product candidate is an enhanced polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia caused by chronic renal (kidney) failure or chemotherapy. ErepoXen uses Lipoxen's PolyXen® platform technology to attach polysialic acid (PSA), a polymer of sialic acid (a biodegradable sugar that is found naturally in the human body) to protein drugs.

The trial is an open label Phase II ICH-GCP compliant trial involving 30 patients with anaemia, across 6 trial centres in India. The primary endpoints of the trial are improved red blood cell count, reticulocytes, hemoglobin and hematocrit. Secondary endpoints will measure safety, a reduction in the frequency of injections versus current EPOs, and immunogenicity. Clinigene International Ltd, a Biocon group company based in Bangalore is the contract research organization running the trial. Results on this trial are scheduled to be reported early Q3 this year.

As reported in early February, the Serum Institute agreed to accelerate the product candidate towards marketability by expanding the planned trial into a fully integrated Phase II US FDA compliant trial and to meet the additional costs associated.

Commenting on the Phase II trial, M. Scott Maguire, CEO of Lipoxen, said: "The commencement of our Phase II ErepoXen trial with the Serum Institute under European regulations in India is a very exciting step forward. EPO is a currently $9B drug and is injected 1-3 times per week. Our EPO is designed to last for one month so we are very excited about moving this potential blockbuster candidate into patient trials having had a successful Phase I trial. Not only will the trial measure the potential benefits of our enhanced EPO product candidate, but positive results will assist Lipoxen to execute further licensing deals that combine our versatile PolyXen® platform technology with existing protein drugs."

RNS Number : 7796G Lipoxen PLC 08 February 2010

For immediate release 8 February 2010

Lipoxen plc

('Lipoxen' or 'the Company')

Lipoxen's Polysialylated G-CSF StimuXen* Technology

Granted European Patent

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, announces that it has been granted patents for its Polysialylated G-CSF StimuXen* Technology in six European territories, including the UK, Germany, France, Spain, Italy and Switzerland.

This technology is based on polysialic acid (PSA, a polymer occurring naturally in humans), which extends a protein's active life. PSA is biodegradable, non-immunogenic and non-toxic and is also therefore expected to avoid the toxicity attributed to polyethylene glycol (PEG) in PEGylated protein drug candidates.

StimuXen* uses Lipoxen's patented PolyXen* technology to attach polysialic acid onto the N-terminal of G-CSF to produce polysialylated G-CSF. The patent application related to it is recent and has now been granted in Europe. Preclinical work with StimuXen* has shown improved pharmacokinetics and pharmacodynamics which are similar to those of the longest-acting version of G-CSF on the market whose patent expires in 2015. G-CSF generated global sales of $5.2B in 2008.

How it works

The G-CSF (granulocyte-colony stimulating factor) stimulates the bone marrow to produce more white blood cells (WBC).

A major side effect of chemotherapy is a reduction in the number of WBC which can lead to a patient's reduced ability to fight infection, consequent to which chemotherapy may be postponed or the dose lowered, neither outcome being optimal for the preferred treatment. Prescription of G-CSF acts to protect the body's level of WBC during chemotherapy and is usually administered daily for up to 14 days.

The leading currently available G-CSF therapy is administered once with each cycle of chemotherapy. Lipoxen expects that the improved StimuXen* G-CSF will have a similar treatment profile.

Commenting on the patent grant, M. Scott Maguire, CEO of Lipoxen, said: "We are confident that StimuXen*, which is currently in pre-clinical development, could be as successful as our two potential billion dollar block-buster products in clinical development, SuliXen*, a long acting insulin, and ErepoXen*, a long-acting erythropoietin (EPO) both of which are based on this PolyXen* technology."

RNS Number : 7252G Lipoxen PLC 05 February 2010

FOR IMMEDIATE RELEASE 5 February 2010

Lipoxen plc

('Lipoxen' or 'the Company')

Trading and Programme Update

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, provides a trading update for the period ended 31 December 2009, prior to announcing its final results in April 2010.

Lipoxen reports that, due to a delay in the Phase II clinical trials for long-acting EPO and Insulin, the potential licensing revenues accompanying these candidates did not materialize in H2 2009 as originally expected; as a consequence the Company did not meet its revenue expectations for the second half of 2009.

While operating costs remained tightly controlled, the quantum of cost reduction was not enough to offset the level of revenue shortfall. As a result, the Company's net cash position of £1.02 million at 31 December 2009 was below management expectations. To this end Lipoxen will continue to review its cash requirements whilst pursuing revenue from licensing deals and other funding options.

Importantly Lipoxen has implemented a laboratory restructuring to move the Company's focus from a scientific research-driven and intellectual property company to one focused on maximising near term commercial opportunities in FY2010 for its platform technologies and lead projects. This has involved some staff changes, including the departure of Dr Peter Laing (former Chief Operating Officer of the Company's operating subsidiary, Lipoxen Technologies Limited). As announced in September 2009, the Company appointed Dr David Moss as Director of Projects to deliver on the Company's commercial objectives.

Lead Projects Update

ErepoXen

The Serum Institute of India ("Serum Institute"), Lipoxen's partner responsible for conducting its Phase II trial ErepoXen in India, has agreed to accelerate the product candidate towards marketability by expanding the planned trial into a fully integrated Phase II US FDA compliant trial. This has necessitated the engagement of a specialised Contract Research Organisation to carry out the multi-centre trial and new regulatory permissions. Although the project experienced an interim delay as a result, the required documentation has now been submitted to the Indian Regulatory Authority (DCGI) and Lipoxen expects to announce formal dosing of the first patient in Q1 of 2010.

The additional cost of the expanded Indian ErepoXen Phase II trial will be met by the Serum Institute. This however has culminated in the Serum Institute taking the decision that it is no longer in a position to fund the earlier stage ErepoXen Phase I trial in Canada, as previously agreed. As a result, the Canadian trial is on hold until Lipoxen concludes an alternative funding route.

SuliXen

FDS Pharma ("FDS"), Lipoxen's Russian counterparty responsible for the Company's Phase II Insulin trial of SuliXen in Russia, was unable to commence the trial at the end of 2009. In consultation with FDS, the Company is resetting the timelines for this trial with a view to initiating it in the first half of 2010.

Initial results from the Barbara Davis Institute study of SuliXen for Type 1 diabetes have indicated that this study will be extended through Q1 of 2010. While the Company initially expected to report on this study in Q4 of 2009, following the extension of the study, Lipoxen now anticipates being in a position to report in Q2 this year.

H1N1 Influenza Vaccine

As announced at the end of September 2009, Lipoxen has been appointed the lead member of the grant consortium to develop a novel H1N1 influenza vaccine. This programme is being funded by the UK Technology Strategy Board. While still at an early preclinical stage, this programme is progressing well and, when the latter stages of the programme have been successfully attained, Lipoxen expects to apply for further funding to move the vaccine candidate into the clinic within the next 12 months.

Baxter Healthcare

Lipoxen's Factor VIII project, which is partnered with Baxter, is progressing well and, as expected, the Company anticipates lead Product Candidate declaration in the first half of this year. Baxter is now the Company's third largest shareholder and sees the potential for broadening the collaboration this year.

HIV and Malaria Vaccine

The Company's HIV project, partnered with the world's leading HIV vaccine organization, International AIDS Vaccine Initiative, remains on track to report in Q1 of 2010 and Lipoxen's novel malaria project partnered with PATH Malaria Vaccine Initiative and the US NIH, is expected to report in the same time frame.

siRNA Delivery Project

Lipoxen's agreement, announced in June 2009, for its siRNAblate technology to evaluate the effectiveness of combining its partner's (currently undisclosed) proprietary siRNA with Lipoxen's platform technology, is progressing well and the Company will provide a further update in the near future.

Other Projects

The Company's collaboration with Pharmasynthez ZAO, announced in November 2009, to apply Lipoxen's ImuXen and PolyXen proprietary technologies to a broad range of six drug and vaccine candidates, is progressing well. This project will provide human proof of concept data on Lipoxen's vaccine platform technology as early as the end of this year.

Commenting on the trading update, M. Scott Maguire, CEO of Lipoxen, said: "We are delighted that the Serum Institute has decided to extend the Phase II ErepoXen trial in India to a fully compliant FDA trial. While incurring an initial delay, we are very pleased that the product will be accelerated to market.

"Following the recent restructuring, Lipoxen is better able to focus on delivering the near term commercial opportunities for its promising platform technologies. We therefore are confident of delivering value enhancing newsflow over the course of the next few months."